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A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) in Patients With Advanced or Metastatic Liver Cancer

7 mai 2014 mis à jour par: Hoffmann-La Roche

A Single-arm, Open-label Study of Avastin Plus Xeloda on Objective Treatment Response in Patients With Advanced or Metastatic Liver Cancer Who Have Had no Previous Cytotoxic Chemotherapy

This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

45

Phase

  • Phase 2

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Australie
      • Melbourne, Australie, 3181
  • Hong Kong
      • Hong Kong, Hong Kong
  • Singapour
      • Singapore, Singapour, 169610
  • Taïwan
      • Kueishan, Taïwan, 333
      • Taipei, Taïwan, 114
      • Taipei, Taïwan, 00112
      • Taipei, Taïwan, 106

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

Inclusion Criteria:

  • adult patients >=18 years of age;
  • advanced or metastatic liver cancer;
  • >=1 measurable lesion.

Exclusion Criteria:

  • current radiotherapy, chemotherapy, or other experimental therapies;
  • prior cytotoxic chemotherapy;
  • major surgery, open biopsy, or traumatic injury within 28 days of study entry;
  • history of a malignancy during the last 5 years, other than cutaneous basal cell cancer or in situ cervical cancer.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Avastin + Xeloda
Médicament: bevacizumab [Avastin]
7.5mg/kg iv on day 1 of each 3 week cycle.
Médicament: capecitabine [Xeloda]
1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Objective Response (OR)
Délai: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Percentage of participants with OR based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Percentage of Participants With Disease Control
Délai: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
The percentage of participants with disease control was based on assessment of confirmed CR, PR, or stable disease (SD) according to RECIST criteria. Confirmed responses were those that persisted on repeat imaging study at least 4 weeks after initial documentation of response. The best overall response achieved within the time from first drug administration to progressive disease or end of study was reported. CR was defined as complete disappearance of all target lesions and non-target disease, with the normalization of tumor marker levels. No new lesions. PR was defined as ≥ 30 % decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target lesions. Persistence of one or more non-target lesion(s) or/and maintenance of tumor marker levels above the normal limits. No new lesions. SD was defined as not qualifying for PR or progressive disease.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to Disease Progression - Percentage of Participants With an Event
Délai: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to Disease Progression
Délai: Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of their tumor assessment.
Screening; Weeks 6, 12, 18, 24, and 30; Every 3 months through follow-up
Time to Disease Progression - Percentage of Participants Progression-free at 12 Months
Délai: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Time to progression was measured from time of treatment commencement to time of disease progression, or the date of death. Participants who were not progressed at the time of study completion (including participants who died before progressive disease) or who were lost to follow-up were censored at the date of last tumor assessment.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival - Percentage of Participants With an Event
Délai: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival
Délai: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive. Median Overall Survival was estimated using the Kaplan-Meier method.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival - Percentage of Participants Event Free at 12 Months
Délai: Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.
Overall Survival was defined as the time in months from randomization to date of death due to any cause. Participants without an event were censored the last time they were known to be alive.
Day 1, Weeks 1-18, Weeks 24 and 30, then every 3 months until death.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Hoffmann-La Roche

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 mai 2005

Achèvement primaire (Réel)

1 mars 2008

Achèvement de l'étude (Réel)

1 mars 2008

Dates d'inscription aux études

Première soumission

3 décembre 2013

Première soumission répondant aux critères de contrôle qualité

11 décembre 2013

Première publication (Estimation)

17 décembre 2013

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

6 juin 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

7 mai 2014

Dernière vérification

1 mai 2014

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • ML18469

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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